Medical system and monitor device with angular leakage detection

ABSTRACT

An ostomy system and a monitor device is disclosed, the monitor device being for an ostomy system comprising an ostomy appliance with a base plate and/or a sensor assembly part having a first adhesive layer with (a proximal side configured for attachment of the base plate and/or the sensor assembly part to the skin surface of a user, the first adhesive layer having a stomal opening with a center point, the monitor device comprising: a processor configured to: transmit a leakage monitor signal comprising monitor data indicative of presence of fluid in a sensing zone via the second interface.

The present disclosure relates to an ostomy system and a monitor device.An ostomy system, and devices of the ostomy system are disclosed. Theostomy system comprises an ostomy appliance and a monitor device. Inparticular, the present disclosure relates to monitor device withangular leakage detection, thus enabling or facilitating leakageclassification and/or detection for an ostomy appliance and/ormonitoring the operation of an ostomy appliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate and/or a sensorassembly part,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8,

FIG. 10 is a distal view of a part of the base plate and/or sensorassembly part including a monitor interface,

FIG. 11 is a distal view of the electrode configuration of FIG. 6,

FIG. 12 is a distal view of an exemplary electrode configuration,

FIG. 13 is a distal view of an exemplary masking element,

FIG. 14 is a distal view of an exemplary first adhesive layer,

FIG. 15 is a distal view of an exemplary electrode configuration, and

FIG. 16 is a flow diagram of an exemplary method.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user, when the appliance is fitted on a user andthe distal side is the opposite side or surface—the side or surfacefurthest away from the user in use.

The axial direction is defined as the direction of the stoma, when auser wears the appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

A radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to the ostomy system and devices thereof are disclosed.An accessory device (also referred to as an external device) may be amobile phone or other handheld device. An accessory device may be apersonal electronic device, e.g. a wearable, such as a watch or otherwrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of leakage ofoutput between a skin surface and first adhesive layer, and in turnenable providing an indication to the user of the leakage withoutexperiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

The ostomy appliance includes a base plate, such as a monolithic,one-piece base plate, e.g. integrated with a sensor assembly part, or abase plate and a separate sensor assembly part, such as a sensorassembly part to be subsequently applied to a base plate. For example,to allow an arbitrary base plate, such as a conventional base plate, toachieve the features as described herein. Features as described withrespect to the base plate herein may be provided by a sensor assemblypart to be applied to a base plate, e.g. by the user. A sensor assemblypart may be adapted to adhere to an ostomy plate.

A disclosed method of attaching a base plate to a user's stoma and/orskin surrounding the stoma, such as the peristomal skin area, maycomprise attaching a sensor assembly part to a base plate and attachingthe base plate, e.g. together with the attached sensor assembly part, tothe user's stoma and/or skin surrounding the stoma, such as theperistomal skin area. Alternatively, the method of attaching the baseplate to the user's stoma and/or skin surrounding the stoma may compriseattaching the sensor assembly part to the user's stoma and/or skinsurrounding the stoma and attaching the base plate to the user's stomaand/or skin surrounding the stoma above the attached sensor assemblypart.

A base plate and/or a sensor assembly part for an ostomy appliance isdisclosed, the base plate and/or the sensor assembly part comprising afirst adhesive layer with a proximal side configured for attachment ofthe base plate and/or the sensor assembly part to the skin surface of auser, the first adhesive layer having a stomal opening, such as a firstadhesive stomal opening, with a center point; and a plurality ofelectrodes including a first leakage electrode, a second leakageelectrode, and a third leakage electrode, wherein the plurality ofelectrodes is configured to detect presence of fluid on the proximalside of the first adhesive layer in a primary sensing zone and asecondary sensing zone. The primary sensing zone is arranged in aprimary angle space from the center point of the first adhesive layerand the secondary sensing zone is arranged in a secondary angle spacefrom the center point of the first adhesive layer.

Further, a monitor device for an ostomy system is disclosed, the ostomysystem comprising an ostomy appliance with a base plate and/or a sensorassembly part having a first adhesive layer with a proximal sideconfigured for attachment of the base plate and/or the sensor assemblypart to the skin surface of a user, the first adhesive layer having astomal opening, such as a first adhesive stomal opening, with a centerpoint, the monitor device comprising a processor; memory; a firstinterface connected to the processor and the memory, the first interfaceconfigured for obtaining ostomy data from the base plate and/or thesensor assembly part coupled to the first interface, the ostomy datacomprising primary leakage ostomy data from a primary electrode set ofthe base plate and/or the sensor assembly part, and secondary leakageostomy data from a secondary electrode set of the base plate and/or thesensor assembly part; and a second interface connected to the processor,wherein the processor is configured to: obtain primary leakage parameterdata based on the primary leakage ostomy data; obtain secondary leakageparameter data based on the secondary leakage ostomy data; detectpresence of fluid on the proximal side of the first adhesive layer in aprimary sensing zone based on the primary leakage parameter data, theprimary sensing zone arranged in a primary angle space from the centerpoint of the first adhesive layer; detect presence of fluid on theproximal side of the first adhesive layer in a secondary sensing zonebased on the secondary leakage parameter data, the secondary sensingzone arranged in a secondary angle space from the center point of thefirst adhesive layer; in accordance with a detection of presence offluid in the primary sensing zone, transmit a primary leakage monitorsignal comprising monitor data indicative of presence of fluid in theprimary sensing zone via the second interface; and in accordance with adetection of presence of fluid in the secondary sensing zone, transmit asecondary leakage monitor signal comprising monitor data indicative ofpresence of fluid in the secondary sensing zone via the secondinterface.

Also disclosed is an ostomy system comprising an ostomy appliance and amonitor device as described herein.

Further, a method of monitoring a base plate and/or a sensor assemblypart of an ostomy appliance is disclosed, the base plate and/or thesensor assembly part comprising a first adhesive layer and a pluralityof electrodes, the first adhesive layer having a proximal sideconfigured for attachment of the base plate and/or the sensor assemblypart to the skin surface of a user and a stomal opening, such as a firstadhesive stomal opening, with a center point, the plurality ofelectrodes including a first leakage electrode, a second leakageelectrode, and a third leakage electrode. The method comprises obtaininga primary sensor signal (primary leakage ostomy data) from the firstleakage electrode and the second leakage electrode; detecting presenceof fluid on the proximal side in a primary sensing zone based on theprimary sensor signal (primary leakage ostomy data); obtaining asecondary sensor signal (secondary leakage ostomy data) from the secondleakage electrode and the third leakage electrode or from the firstleakage electrode and the third leakage electrode; detecting presence offluid on the proximal side in a secondary sensing zone based on thesecondary sensor signal (secondary leakage ostomy data); and inaccordance with detection of presence of fluid in the primary sensingzone and/or the secondary sensing zone, providing a leakage indicatorindicative of the sensing zone in which presence of liquid has beendetected. The method may be performed with a base plate and/or a sensorassembly part as disclosed herein.

The method may comprise obtaining a tertiary sensor signal (tertiaryleakage ostomy data) from two leakage electrodes; detecting presence offluid on the proximal side in a tertiary sensing zone based on thetertiary sensor signal (tertiary leakage ostomy data); and in accordancewith detection of presence of fluid in the tertiary sensing zone,providing a leakage indicator indicative of the sensing zone in whichpresence of liquid has been detected.

The method may comprise obtaining a quaternary sensor signal (quaternaryleakage ostomy data) from two leakage electrodes; detecting presence offluid on the proximal side in a quaternary sensing zone based on thequaternary sensor signal (quaternary leakage ostomy data); and inaccordance with detection of presence of fluid in the quaternary sensingzone, providing a leakage indicator indicative of the sensing zone inwhich presence of liquid has been detected.

The base plate and/or the sensor assembly part comprises a firstadhesive layer. During use, the first adhesive layer adheres to theuser's skin (peristomal area) and/or to additional seals, such assealing paste, sealing tape and/or sealing ring. Thus, the firstadhesive layer may be configured for attachment of the base plate and/orthe sensor assembly part to the skin surface of a user. The firstadhesive layer has a stomal opening, such as a first adhesive stomalopening, with a center point or is at least prepared for forming astomal opening with a center point. A base plate and/or a sensorassembly part according to the present disclosure enables detection ofpresence and angular position of fluid or output on the proximal side ofthe first adhesive layer (between a skin surface of the user and theproximal surface of the first adhesive layer).

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocolloids. The first composition may comprise one or more watersoluble or water swellable hydrocolloids.

The first composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The firstcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the first compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thefirst composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids, and synthetic hydrocolloids. The firstcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethyl cellulose (CMC). The first composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

It is an advantage of the present disclosure that an optimum or improveduse of an ostomy appliance is provided. In particular, the presentdisclosure facilitates that a base plate is not changed too late(leading to adhesive failure, leakage and/or skin damage), or at leastthat a user is informed that a leakage will happen, is happening, or hashappened. Accordingly, the user or a health care professional is able tomonitor and plan the use of the ostomy appliance.

Further, determination of moisture pattern types or angular leakagepatterns is useful in helping to reduce the risk of a user experiencingleakage from an ostomy appliance. Further, determination of moisturepattern types and classification of operating states and/or leakagepatterns of the ostomy appliance is further useful in helping reduce therisk of skin damage to a user.

The present disclosure provides an efficient, and easy-to-use ostomyappliance system with a high degree of comfort for a user.

The primary sensing zone of the base plate and/or the sensor assemblypart is arranged in a primary angle space from the center point of thefirst adhesive layer. The primary angle space may span a primary anglein the range from 45° to 315°, such as in the range from 45° to 135°.The primary angle may depend on the number of angular sensing zones onthe base plate and/or the sensor assembly part. For example, the primaryangle may be about 180°±15°, e.g. for a base plate and/or a sensorassembly part with two or more sensing zones. The primary angle may beabout 120°±15°, e.g. for a base plate and/or a sensor assembly part withtwo, three or more sensing zones. The primary angle may be about90°±15°, e.g. for a base plate and/or a sensor assembly part with two,three, four or more sensing zones.

The secondary sensing zone is arranged in a secondary angle space fromthe center point of the first adhesive layer. The secondary angle spacemay span a secondary angle in the range from 45° to 315°, such as in therange from 45° to 135°. The secondary angle may depend on the number ofangular sensing zones on the base plate and/or the sensor assembly part.For example, the secondary angle may be about 180°±15°, e.g. for a baseplate and/or a sensor assembly part with two or more sensing zones. Thesecondary angle may be about 120°±15°, e.g. fora base plate and/or asensor assembly part with two, three or more sensing zones. Thesecondary angle may be about 90°±15°, e.g. for a base plate and/or asensor assembly part with two, three, four or more sensing zones.

The plurality of electrodes may be configured to detect presence offluid on the proximal side in a tertiary sensing zone, the tertiarysensing zone arranged in a tertiary angle space from the center point ofthe first adhesive layer.

The tertiary angle space may span a tertiary angle in the range from 45°to 315°, such as in the range from 45° to 180°, for example in the rangefrom 45° to 135°. The tertiary angle may depend on the number of angularsensing zones on the base plate and/or the sensor assembly part. Forexample, the tertiary angle may be about 180°±15°, e.g. for a base plateand/or a sensor assembly part with three or more sensing zones. Thetertiary angle may be about 120°±15°, e.g. fora base plate and/or asensor assembly part with three or more sensing zones. The tertiaryangle may be about 90°±15°, e.g. for a base plate and/or a sensorassembly part with three, four or more sensing zones.

The primary sensing zone and the secondary sensing zone may be separatesensing zones, i.e. non-overlapping. The primary sensing zone and thetertiary sensing zone may be separate sensing zones, i.e.non-overlapping. The secondary sensing zone and the tertiary sensingzone may be separate sensing zones, i.e. non-overlapping.

The primary sensing zone, the secondary sensing zone, and/or thetertiary sensing zone may cover electrodes embedded in the firstadhesive layer as well as leakage electrodes being exposed to thesurroundings. Thereby, the propagation or absorption of moisture in thefirst adhesive layer may be detected in one or more of the sensingzones, thereby providing for the determination of the direction ofmoisture propagation in the first adhesive layer. Likewise, outputpropagating between the skin of the wearer and the first adhesive layermay be determined by the exposed leakage electrodes. The leakageelectrodes may be exposed by means of sensor point openings as describedbelow.

The first leakage electrode may comprise one or more primary firstsensing parts arranged in the primary sensing zone. The number ofprimary first sensing parts may be in the range from 3 to 10, e.g. 4, 5,6 or 7. The number of primary first sensing parts may depend on theprimary angle and/or the radial distance of primary first sensing partsfrom the center point. The first leakage electrode may comprise one ormore tertiary first sensing parts arranged in the tertiary sensing zone.The number of tertiary first sensing parts may be in the range from 3 to10, e.g. 4, 5, 6 or 7. The number of tertiary first sensing parts maydepend on the tertiary angle and/or the radial distance of tertiaryfirst sensing parts from the center point.

The second leakage electrode comprises one or more primary secondsensing parts arranged in the primary sensing zone. The number ofprimary second sensing parts may be in the range from 3 to 10, e.g. 4,5, 6 or 7. The number of primary second sensing parts may depend on theprimary angle and/or the radial distance of primary second sensing partsfrom the center point. The second leakage electrode comprises one ormore secondary second sensing parts arranged in the secondary sensingzone. The number of secondary second sensing parts may be in the rangefrom 3 to 10, e.g. 4, 5, 6 or 7. The number of secondary second sensingparts may depend on the secondary angle and/or the radial distance ofsecondary second sensing parts from the center point.

The third leakage electrode may comprise one or more secondary thirdsensing parts arranged in the secondary sensing zone. The number ofsecondary third sensing parts may be in the range from 3 to 10, e.g. 4,5, 6 or 7. The number of secondary third sensing parts may depend on thesecondary angle and/or the radial distance of secondary third sensingparts from the center point. The third leakage electrode may compriseone or more tertiary third sensing parts arranged in the tertiarysensing zone. The number of tertiary third sensing parts may be in therange from 3 to 10, e.g. 4, 5, 6 or 7. The number of tertiary thirdsensing parts may depend on the tertiary angle and/or the radialdistance of tertiary third sensing parts from the center point.

The first adhesive layer may have a plurality of sensor point openings.A sensor point opening of the first adhesive layer is configured tooverlap a (sensing) part of a leakage electrode, e.g. to form a sensorpoint. Sensing parts of the first leakage electrode may be exposed tothe proximal side of the first adhesive layer via sensor point openingsin the first adhesive layer and/or masking element. Sensing parts of thesecond leakage electrode may be exposed to the proximal side of thefirst adhesive layer via sensor point openings in the first adhesivelayer and/or masking element. Sensing parts of the third leakageelectrode may be exposed to the proximal side of the first adhesivelayer via sensor point openings in the first adhesive layer and/ormasking element.

A distance between two neighbouring sensor point openings may be in therange from 1 mm to 20 mm.

A sensor point opening of the first adhesive layer may have a suitableshape and size facilitating access to a leakage electrode from theproximal side of the first adhesive layer. A sensor point opening thefirst adhesive layer may have a circular or oval shape. A sensor pointopening the first adhesive layer may have a shape of a rectangle orsquare optionally with rounded corners.

A minimum extension of a sensor point opening of the first adhesivelayer may be at least 0.5 mm, such as at least 1 mm. A sufficientlylarge minimum extension reduces the risk of the first adhesive layer,due to the materials flow capabilities, closing the sensor point openingor at least partly or fully covering the sensing part of thecorresponding leakage electrode.

A maximum extension of a sensor point opening of the first adhesivelayer may be less than 20 mm.

An exemplary sensor point opening of the first adhesive layer may have aminimum extension, e.g. measured radially from the center point, in therange from 1 mm to 4 mm and/or a maximum extension, e.g. measuredcircumferentially around the center point, in the range from 2 mm to 6mm.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The number of primary sensor pointopenings may depend on the primary angle and/or the radial distance ofprimary sensor point openings from the center point. In one or moreexemplary base plates and/or sensor assembly parts, the number ofprimary sensor point openings is in the range from 5 to 20, such as inthe range from 7 to 15. The primary sensor point openings may compriseone or more primary first sensor point openings and one or more primarysecond sensor point openings, the primary first sensor point openingsconfigured to overlap (sensing) parts of a leakage electrode and theprimary second sensor point openings configured to overlap (sensing)parts of another leakage electrode different from the leakage electrodeat least partly overlapped by the primary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The number of secondary sensor pointopenings may depend on the secondary angle and/or the radial distance ofsecondary sensor point openings from the center point. In one or moreexemplary base plates and/or sensor assembly parts, the number ofsecondary sensor point openings is in the range from 5 to 20, such as inthe range from 7 to 15. The secondary sensor point openings may compriseone or more secondary first sensor point openings and one or moresecondary second sensor point openings, the secondary first sensor pointopenings configured to overlap (sensing) parts of an electrode and thesecondary second sensor point openings configured to overlap (sensing)parts of another electrode different from the electrode at least partlyoverlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The number of tertiary sensor pointopenings may depend on the tertiary angle and/or the radial distance oftertiary sensor point openings from the center point. In one or moreexemplary base plates and/or sensor assembly parts, the number oftertiary sensor point openings is in the range from 5 to 20, such as inthe range from 7 to 15. The tertiary sensor point openings may compriseone or more tertiary first sensor point openings and one or moretertiary third sensor point openings, the tertiary first sensor pointopenings configured to overlap (sensing) parts of a (first) leakageelectrode and the tertiary third sensor point openings configured tooverlap (sensing) parts of another (third) leakage electrode differentfrom the electrode at least partly overlapped by the tertiary firstsensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate and/or the sensor assembly part may comprise a secondlayer. The second layer may be an adhesive layer. The second layer mayhave a second radial extension that is larger than a first radialextension of the first adhesive layer at least in a first angular rangeof the base plate and/or the sensor assembly part. Accordingly, a partof a proximal surface of the second layer may be configured forattachment to the skin surface of a user. The part of a proximal surfaceof the second layer configured for attachment to the skin surface of auser is also denoted the skin attachment surface of the second adhesivelayer. The second layer may have a stomal opening, such as a secondlayer stomal opening and/or a second adhesive stomal opening, with acenter point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocolloids. The second composition may comprise one or morewater soluble or water swellable hydrocolloids.

The second composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The secondcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the second compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thesecond composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids, and synthetic hydrocolloids. The secondcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethyl cellulose (CMC). The second composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocolloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively, or additionally,the second adhesive layer may be thinner than the first adhesive layer.Alternatively, or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively, or additionally, the second adhesive layer may be lessmoldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

In the present disclosure, a reference to ground electrode (or to fourthelectrode part of the ground electrode) is a reference to the firstleakage electrode. Thus, throughout the present disclosure the firstleakage electrode is also referred to as or denoted ground electrode. Inother words, the ground electrode acts as the first leakage electrode.

In the present disclosure, a reference to fourth electrode is areference to the second leakage electrode. Thus, throughout the presentdisclosure the second leakage electrode is also referred to as ordenoted fourth electrode. In other words, the fourth electrode acts asthe second leakage electrode.

In the present disclosure, a reference to fifth electrode is a referenceto the third leakage electrode. Thus, throughout the present disclosurethe third leakage electrode is also referred to as or denoted fifthelectrode. In other words, the fifth electrode acts as the third leakageelectrode.

The base plate and/or the sensor assembly part may comprise one or moreelectrodes, such as a plurality of electrodes, such as two, three, four,five, six, seven or more electrodes. The sensor assembly part may beapplied to the base plate, such as to provide the base plate with theone or more electrodes.

The electrodes, e.g. some or all the electrodes, may be arranged betweenthe first adhesive layer and the second adhesive layer. The electrodesmay be arranged in an electrode assembly, e.g. an electrode layer. Anelectrode comprises a connection part for connecting the electrodes toother components and/or interface terminals/terminal elements. Anelectrode may comprise one or more conductor parts and/or one or moresensing parts. A conductor part may be considered part of an electrodeconnecting two or more sensing parts, and/or connecting a sensing partwith a connection part of the respective electrode. A sensing part maybe considered a part of the electrode being suitable for sensing, e.g.liquid, such as liquid content, and/or output, such as output resultingfrom a leakage, or an imminent leakage. The sensing part may be suitablefor sensing e.g. by its shape, said shape potentially being circular,oval, or rectangular. Thus, the conductor part may conduct a signalarising from the sensing part. An electrode may comprise alternatingconductor parts and sensing parts. The electrode assembly may bearranged between the first adhesive layer and the second adhesive layer.The base plate and/or the sensor assembly part, e.g. the electrodeassembly, may comprise a first electrode, a second electrode andoptionally a third electrode. The base plate and/or the sensor assemblypart, e.g. the electrode assembly, may comprise a fourth electrodeand/or a fifth electrode. The base plate and/or the sensor assemblypart, e.g. the electrode assembly, optionally comprises a sixthelectrode. The base plate and/or the sensor assembly part, e.g. theelectrode assembly, may comprise a ground electrode. The groundelectrode may comprise a first electrode part. The first electrode partof the ground electrode may form a ground or reference for the firstelectrode. The ground electrode may comprise a second electrode part.The second electrode part of the ground electrode may form a ground orreference for the second electrode. The ground electrode may comprise athird electrode part. The third electrode part of the ground electrodemay form a ground or reference for the third electrode. The groundelectrode may comprise a fourth electrode part. The fourth electrodepart of the ground electrode may form a ground or reference for thefourth electrode and/or the fifth electrode. The ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

The ground electrode may comprise a first electrode part and a secondelectrode part, the first electrode part forming the ground for thefirst electrode and the second electrode part forming the ground for thesecond electrode. The first electrode part may form a closed loop.

Two electrodes of the electrode assembly may form a sensor. The firstleakage electrode and the second leakage electrode may form a primaryleakage sensor or primary leakage electrode set for detecting presenceof fluid on the proximal side of the first adhesive layer in the primarysensing zone. The second leakage electrode and the third leakageelectrode may form a secondary leakage sensor or secondary leakageelectrode set for detecting presence of fluid on the proximal side ofthe first adhesive layer in the secondary sensing zone. The firstleakage electrode and the third leakage electrode may form a tertiaryleakage sensor or tertiary leakage electrode set for detecting presenceof fluid on the proximal side of the first adhesive layer in thetertiary sensing zone.

An electrode may comprise a sensing part or a plurality of sensingparts, i.e. the part(s) of an electrode that are used for sensing. Thefirst electrode may comprise a first sensing part, the first sensingpart contacting the first adhesive layer and arranged at least partlyannularly around the stomal opening. The first electrode may comprise afirst conductor part insulated from the first adhesive layer, e.g. by amasking element arranged between the first conductor part and the firstadhesive layer. The first sensing part may extend at least 270 degreesaround the stomal opening, such as at least 300 degrees around thestomal opening. The first sensing part of the first electrode may bearranged at a first ground distance from the first electrode part of theground electrode. The first ground distance may be less than 5 mm, suchas less than 3 mm, e.g. about 1.0 mm.

The second electrode may comprise a second sensing part, the secondsensing part contacting the first adhesive layer. The second sensingpart may be arranged at least partly annularly around the stomalopening. The second sensing part may extend at least 270 degrees aroundthe stomal opening, such as at least 300 degrees around the stomalopening. The second sensing part of the second electrode may be arrangedat a second ground distance from the second electrode part of the groundelectrode. The second ground distance may be less than 5 mm, such asless than 3 mm, e.g. about 1.0 mm.

The first sensing part may be arranged at a first radial distance fromthe center point and the second sensing part may be arranged at a secondradial distance from the center point. The second radial distance may belarger than the first radial distance. The second electrode may comprisea second conductor part insulated from the first adhesive layer, e.g. bya masking element arranged between the second conductor part and thefirst adhesive layer. The first radial distance may vary as a functionof an angular position with respect to a zero direction from the centerpoint. The second radial distance may vary as a function of an angularposition with respect to a zero direction from the center point. Thezero direction may be defined as the vertical upward direction when thebase plate and/or the sensor assembly part is in its intended wearingposition on an upstanding user.

The first radial distance may be in the range from 5 mm to 40 mm, suchas in the range from 10 mm to 25 mm, e.g. about 14 mm. The second radialdistance may be in the range from 10 mm to 50 mm, such as in the rangefrom 10 mm to 25 mm, e.g. about 18 mm.

The base plate and/or the sensor assembly part may comprise a thirdelectrode comprising a third connection part. The ground electrode mayform a ground for the third electrode. The ground electrode may comprisea third electrode part, the third electrode part forming the ground forthe third electrode. The third electrode may comprise a third conductorpart insulated from the first adhesive layer, e.g. by a masking elementarranged between the third conductor part and the first adhesive layer.The third electrode may comprise a third sensing part, the third sensingpart contacting the first adhesive layer. The third sensing part may bearranged at least partly annularly around the stomal opening. The thirdsensing part may be arranged at a third radial distance from the centerpoint. The third radial distance may be larger than the first radialdistance and/or larger than the second radial distance. The third radialdistance may be in the range from 15 mm to 50 mm. such as in the rangefrom 20 mm to 30 mm, e.g. about 26 mm. The third sensing part may extendat least 270 degrees around the stomal opening, such as at least 300degrees around the stomal opening. The third sensing part of the thirdelectrode may be arranged at a third ground distance from the thirdelectrode part of the ground electrode. The third ground distance may beless than 5 mm, such as less than 3 mm, e.g. about 1.0 mm. A base plateand/or a sensor assembly part with a ground electrode, a firstelectrode, a second electrode, and a third electrode allows for afailsafe base plate and/or sensor assembly part in case e.g. the firstelectrode is cut or otherwise destroyed during preparation of the baseplate and/or the sensor assembly part.

The base plate and/or the sensor assembly part comprises a secondleakage electrode also denoted a fourth electrode, the fourth electrodecomprising a fourth connection part. The ground electrode (first leakageelectrode) may form a ground for the fourth electrode. The groundelectrode may comprise a fourth electrode part, the fourth electrodepart forming the ground for the fourth electrode. The fourth electrodemay comprise one or a plurality of fourth sensing parts, such as atleast five fourth sensing parts. The fourth sensing parts may bedistributed around the stomal opening or a center point thereof. Thefourth sensing parts may be arranged at respective fourth radialdistances from the center point. The fourth radial distance(s) may belarger than the third radial distance. The fourth radial distance(s) maybe in the range from 25 mm to 50 mm, such as about 30 mm

The base plate and/or the sensor assembly part may comprise a fifthelectrode comprising a fifth connection part. The ground electrode mayform a ground for the fifth electrode. The ground electrode may comprisea fifth electrode part, the fifth electrode part forming the ground forthe fifth electrode. The fifth electrode may comprise one or a pluralityof fifth sensing parts, such as at least five fifth sensing parts. Thefifth sensing parts may be distributed around the stomal opening or acenter point thereof. The fifth sensing parts may be arranged atrespective fifth radial distances from the center point. The fifthradial distance may be larger than the third radial distance. The fifthradial distance may be larger than the fourth radial distance. The fifthradial distance(s) may be in the range from 25 mm to 50 mm, such asabout 30 mm.

The first electrode may form an open loop. The second electrode may forman open loop and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The base plate and/or the sensor assembly part may comprise a secondadhesive layer, wherein the plurality of electrodes is arranged betweenthe first adhesive layer and the second adhesive layer.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Thus, oneor more electrodes may be arranged between the support layer and thefirst adhesive layer. The electrode assembly, such as the support layerof the electrode assembly, may have a stomal opening, such as anelectrode assembly stomal opening and/or a support layer stomal opening,with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates and/or sensor assembly parts, the support layer ismade of thermoplastic polyurethane (TPU). The support layer material maybe made of or comprise one or more of polyester, a thermoplasticelastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA),polyurea, and silicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly part, such as the electrodeassembly may comprise a masking element configured to insulate at leastparts of the electrodes from the first adhesive layer of the base plateand/or the sensor assembly part. The masking element may comprise one ormore, such as a plurality of, sensor point openings. The sensor pointopenings may comprise primary sensor point openings and/or secondarysensor point openings. The sensor point openings may comprise tertiarysensor point opening(s). The sensor point openings may comprisequaternary sensor point opening(s). A sensor point opening of themasking element overlaps at least one electrode of the electrodeassembly when seen in the axial direction, e.g. to form a sensor point.For example, a primary sensor point opening may overlap a (sensing) partof the ground electrode and/or a (sensing) part of the fourth electrode.A secondary sensor point opening may overlap a (sensing) part of thefourth electrode and/or a (sensing) part of the fifth electrode. Atertiary sensor point opening may overlap a (sensing) part of the fifthelectrode and/or a (sensing) part of the ground electrode.

The masking element may comprise one or more, such as a plurality of,terminal openings. A terminal opening may overlap with one or moreconnection parts of electrodes. In one or more exemplary base plates,each terminal opening overlaps with a single connection part of anelectrode.

The masking element may comprise polymeric (e.g. polyurethane, PTFE,PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates and/or sensor assembly parts, the masking elementis made of or comprises thermoplastic polyurethane (TPU). In one or moreexemplary base plates and/or sensor assembly parts, the masking elementis made of or comprises polyester. The masking element material may bemade of or comprise one or more of polyester, a thermoplastic elastomer(TPE), polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, andsilicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly part may comprise a firstintermediate element. The first intermediate element may be arrangedbetween the electrodes/electrode layer and the first adhesive layerand/or between the second layer and the first adhesive layer. The firstintermediate layer may be made of an insulating material.

The base plate and/or the sensor assembly part may comprise a releaseliner. The release liner is a protective layer that protects adhesivelayer(s) during transport and storage and is peeled off by the userprior to applying the base plate on the skin. The release liner may havea stomal opening, such as a release liner stomal opening, with a centerpoint.

The base plate and/or the sensor assembly part may comprise a top layer.The top layer is a protective layer protecting the adhesive layer(s)from external strains and stress when the user wears the ostomyappliance. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the top layer. The toplayer may have a stomal opening, such as a top layer stomal opening,with a center point. The top layer may have a thickness in the rangefrom 0.01 mm to 1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, suchas 0.04 mm. The top layer may have a stomal opening with a center point.

The base plate and/or the sensor assembly part may comprise a monitorinterface. The monitor interface may be configured for electricallyand/or mechanically connecting the ostomy appliance (base plate and/orsensor assembly part) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (base plateand/or sensor assembly part) to the monitor device. Thus, the monitorinterface of the base plate and/or the sensor assembly part may beconfigured to electrically and/or mechanically couple the ostomyappliance and the monitor device.

The monitor interface of the base plate and/or the sensor assembly partmay comprise, e.g. as part of a first connector of the monitorinterface, a coupling part for forming a mechanical connection, such asa releasable coupling between the monitor device and the base plateand/or the sensor assembly part. The coupling part may be configured toengage with a coupling part of the monitor device for releasablycoupling the monitor device to the base plate and/or the sensor assemblypart.

The monitor interface of the base plate and/or the sensor assembly partmay comprise, e.g. as part of a first connector of the monitorinterface, a plurality of terminals, such as two, three, four, five,six, seven or more terminals, for forming electrical connections withrespective terminals of the monitor device. The monitor interface maycomprise a ground terminal element forming a ground terminal. Themonitor interface may comprise a first terminal element forming a firstterminal, a second terminal element forming a second terminal andoptionally a third terminal element forming a third terminal. Themonitor interface may comprise a fourth terminal element forming afourth terminal and/or a fifth terminal element forming a fifthterminal. The monitor interface optionally comprises a sixth terminalelement forming a sixth terminal. The terminal elements of the monitorinterface may contact respective electrodes (connection parts) of thebase plate and/or of the sensor assembly part, such as of the electrodeassembly. The first intermediate element may be arranged between theterminal elements and the first adhesive layer. The first intermediateelement may cover or overlap terminal element(s) of the base plateand/or the sensor assembly part when seen in the axial direction. Thus,the first adhesive layer may be protected or experience more evenlydistributed mechanical stress from the terminal elements of the baseplate and/or the sensor assembly part, in turn reducing the risk ofterminal elements penetrating or otherwise damaging the first adhesivelayer. The first intermediate element may protect or mechanically and/orelectrically shield the first adhesive layer from the terminal elementsof the base plate and/or of the sensor assembly part.

A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal end and a proximalend. A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal part, a centre part,and/or a proximal part. The distal part may be between the distal endand the centre part. The proximal part may be between the proximal endand the centre part. The proximal end/proximal part of a terminalelement may contact a connection part of an electrode. A terminalelement, such as the ground terminal element, the first terminalelement, the second terminal element, the third terminal element, thefourth terminal element, the fifth terminal element and/or the sixthterminal element, may be gold plated copper.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate and/or the sensor assembly part has a stomal opening witha center point. The stomal opening of the base plate and/or the sensorassembly part may be formed collectively of stomal opening(s) of thelayers of the base plate and/or the sensor assembly part, such as of thetop layer, the first adhesive layer, the second layer and/or the sensorassembly part. The stomal opening(s) of the layers of the base plateand/or the sensor assembly part, such as of the top layer, the firstadhesive layer, the second layer and/or the sensor assembly part may bealigned to form the stomal opening of the base plate and/or the sensorassembly part. The stomal opening may be a through-going passage of thebase plate and/or the sensor assembly part. The stomal opening may bearranged substantially in the center of the base plate and/or the sensorassembly part. The stomal opening(s) of the layers of the base plateand/or the sensor assembly part may be arranged substantially in thecenter of the respective layer. The stomal opening may be configured toreceive a stoma of the user and/or the stomal opening may be configuredto allow output from the stoma to pass through the stomal opening aninto an ostomy pouch attached to the base plate. For example, the stomalopening may be configured to allow passage of output from a proximalside of the base plate and/or sensor assembly part to a distal side ofthe base plate and/or sensor assembly part. The size and/or shape of thestomal opening may typically be adjusted by the user or nurse beforeapplication of the ostomy appliance to accommodate the user's stoma. Inone or more exemplary base plates, the user forms the stomal openingduring preparation of the base plate for application.

The monitor device comprises a processor and one or more interfaces,such as a first interface and/or a second interface. The monitor devicemay comprise a memory for storing ostomy data.

In one or more exemplary monitor devices, the processor is configured toobtain primary leakage parameter data based on the primary leakageostomy data; optionally obtain secondary leakage parameter data based onthe secondary leakage ostomy data; detect presence of fluid on theproximal side of the first adhesive layer in a primary sensing zonebased on the primary leakage parameter data, the primary sensing zonearranged in a primary angle space from the center point of the firstadhesive layer; optionally detect presence of fluid on the proximal sideof the first adhesive layer in a secondary sensing zone based on thesecondary leakage parameter data, the secondary sensing zone arranged ina secondary angle space from the center point of the first adhesivelayer; in accordance with a detection of presence of fluid in theprimary sensing zone, transmit a primary leakage monitor signalcomprising monitor data indicative of presence of fluid in the primarysensing zone via the second interface; and optionally in accordance witha detection of presence of fluid in the secondary sensing zone, transmita secondary leakage monitor signal comprising monitor data indicative ofpresence of fluid in the secondary sensing zone via the secondinterface.

In one or more exemplary monitor devices, the ostomy data comprisestertiary leakage ostomy data from a tertiary electrode set of the baseplate and/or the sensor assembly part, wherein the processor isconfigured to obtain tertiary leakage parameter data based on theprimary leakage ostomy data; detect presence of fluid on the proximalside of the first adhesive layer in a tertiary sensing zone based on thetertiary leakage parameter data, the tertiary sensing zone arranged in atertiary angle space from the center point of the first adhesive layer;and in accordance with a detection of presence of fluid in the tertiarysensing zone, transmit a tertiary leakage monitor signal comprisingmonitor data indicative of presence of fluid in the tertiary sensingzone via the second interface.

The primary leakage parameter data, the secondary leakage parameterdata, and the tertiary leakage parameter data may be indicative of aresistance between electrodes of the primary electrode set, thesecondary electrode set, and the tertiary electrode set, respectively.

The primary leakage parameter data, the secondary leakage parameterdata, and the tertiary leakage parameter data may be indicative of arate of change in resistance between electrodes of the primary electrodeset, the secondary electrode set, and the tertiary electrode set,respectively.

In one or more exemplary monitor devices, to detect presence of fluid onthe proximal side of the first adhesive layer in a primary sensing zonemay be based on a primary leakage criteria set based on the primaryleakage parameter data, wherein fluid is present in the primary sensingzone if the primary leakage criteria set is satisfied. The primaryleakage criteria set may be based on a primary leakage threshold valuestored in the memory.

The primary leakage criteria set may be given by

(P_PL<TH_PL)

wherein P_PL is a primary leakage parameter based on the primary leakageparameter data and indicative of the resistance between the firstleakage electrode and the second leakage electrode, and TH_PL is aprimary leakage threshold value.

In one or more exemplary monitor devices, to detect presence of fluid onthe proximal side of the first adhesive layer in a secondary sensingzone may be based on a secondary leakage criteria set based on thesecondary leakage parameter data, wherein fluid is present in thesecondary sensing zone if the secondary leakage criteria set issatisfied. The secondary leakage criteria set may be based on asecondary leakage threshold value stored in the memory.

The secondary leakage criteria set may be given by

(P_SL<TH_SL)

wherein P_SL is a secondary leakage parameter based on the secondaryleakage parameter data. The secondary leakage parameter may beindicative of the resistance between the second leakage electrode andthe third leakage electrode, see e.g. FIG. 11. The secondary leakageparameter may be indicative of the resistance between the first leakageelectrode and the third leakage electrode, see e.g. FIG. 12. TH_SL is asecondary leakage threshold value.

In one or more exemplary monitor devices, to detect presence of fluid onthe proximal side of the first adhesive layer in a tertiary sensing zonemay be based on a tertiary leakage criteria set based on the tertiaryleakage parameter data, wherein fluid is present in the tertiary sensingzone if the tertiary leakage criteria set is satisfied. The tertiaryleakage criteria set may be based on a tertiary leakage threshold valuestored in the memory.

The tertiary leakage criteria set may be given by

(P_TL<TH_TL)

wherein P_TL is a tertiary leakage parameter based on the tertiaryleakage parameter data and indicative of the resistance between thefirst leakage electrode and the third leakage electrode, TH_TL is atertiary leakage threshold value, and wherein the tertiary leakageoperating state is indicative of high risk of leakage from the tertiarysensing zone of the ostomy appliance.

The primary leakage threshold value, the secondary leakage thresholdvalue, and the tertiary leakage threshold value may be the same or maybe different.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface. The first interface maybe configured as an appliance interface for electrically and/ormechanically connecting the monitor device to the ostomy appliance.Thus, the appliance interface is configured to electrically and/ormechanically couple the monitor device and the ostomy appliance. Thefirst interface may be configured as an accessory device interface forelectrically and/or mechanically connecting the monitor device to anaccessory device, such as a docking station. The first interface may beconfigured for coupling to a docking station of the ostomy system, e.g.for charging the monitor device and/or for data transfer between themonitor device and the docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate. The coupling part and theterminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensor.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate and/or a sensor assembly part ofthe ostomy appliance.

The ostomy system may comprise a docking station forming analternative/additional accessory device of the ostomy system. Thedocking station may be configured to electrically and/or mechanicallycouple the monitor device to the docking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4. The base plate4 is adapted to support an ostomy pouch (not shown). Further, the ostomysystem 1 comprises a monitor device 6 and an accessory device 8 (mobiletelephone). The monitor device 6 is connectable to the base plate 4 viarespective first connectors of the monitor device 6 and base plate 4.The monitor device 6 is configured for wireless communication with theaccessory device 8. Optionally, the accessory device 8 is configured tocommunicate with a server device 10 of the ostomy system 1, e.g. vianetwork 12. The server device 10 may be operated and/or controlled bythe ostomy appliance manufacturer and/or a service centre. Ostomy dataor parameter data based on the ostomy data are obtained fromelectrodes/sensors of the ostomy appliance 2 with the monitor device 6.The monitor device 6 processes the ostomy data and/or parameter databased on the ostomy data. Based on the processed ostomy data, themonitor device 6 may determine what monitor data that are transmitted tothe accessory device 8. In the illustrated ostomy system, the accessorydevice 8 is a mobile phone, however the accessory device 8 may beembodied as another handheld device, such as a tablet device, or awearable, such as a watch or other wrist-worn electronic device.Accordingly, the monitor device 6 is configured to determine andtransmit monitor data to the accessory device 8. The base plate 4comprises a coupling member 14 in the form of a coupling ring 16 forcoupling an ostomy pouch (not shown) to the base plate (two-part ostomyappliance). The base plate 4 has a stomal opening 18 with a center point19. The size and/or shape of the stomal opening 18 is typically adjustedby the user or nurse before application of the ostomy appliance toaccommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming analternative/additional accessory device of the ostomy system 1. Thedocking station 20 comprises a docking monitor interface including afirst connector 22 configured for electrically and/or mechanicallyconnecting the monitor device 6 to the docking station 20. The dockingmonitor interface may be configured for wirelessly connecting themonitor device to the docking station. The docking station 20 comprisesa user interface 24 for receiving user input and/or providing feedbackto the user on the operational state of the docking station 20. The userinterface 24 may comprise a touch-screen. The user interface 24 maycomprise one or more physical buttons and/or one or more visualindicators, such as light emitting diodes.

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, a processor101, and one or more interfaces, the one or more interfaces including afirst interface 102 (appliance interface) and a second interface 104(accessory interface). The monitor device 6 comprises a memory 106 forstoring ostomy data and/or parameter data based on the ostomy data. Thememory 106 is connected to the processor 101 and/or the first interface102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Thefirst interface 102 comprises a ground terminal 108, a first terminal110, a second terminal 112 and a third terminal 114. The first interface102 optionally comprises a fourth terminal 116 and a fifth terminal 118.The first interface 102 of the monitor device 6 comprises a couplingpart 120 for forming a mechanical connection, such as a releasablecoupling between the monitor device and the base plate. The couplingpart 120 and the terminals 108, 110, 112, 114, 116, and 118 of the firstinterface 102 form (at least part of) a first connector of the monitordevice 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 optionally comprises a sensor unit 140 connected tothe processor 101. For example, the sensor unit 140 may comprise atemperature sensor for feeding temperature data to the processor and/ora G-sensor or accelerometer for feeding acceleration data to theprocessor 101. Additionally or alternatively, the sensor unit 140comprises a humidity sensor and/or an acoustic sensor. The sensor unit140 may comprise alternative and/or additional sensors suitable and/orrelevant to an ostomy system as described.

The processor 101 is configured to obtain primary leakage parameter databased on the primary leakage ostomy data and obtain secondary leakageparameter data based on the secondary leakage ostomy data, wherein theprimary leakage parameter data and the secondary leakage parameter dataare indicative of a resistance between electrodes of the primaryelectrode set and the secondary electrode set, respectively. Further,the processor 101 is configured to detect presence of fluid on theproximal side of the first adhesive layer in a primary sensing zone ofthe base plate and/or the sensor assembly part based on the primaryleakage parameter data, the primary sensing zone arranged in a primaryangle space from the center point of the first adhesive layer and todetect presence of fluid on the proximal side of the first adhesivelayer in a secondary sensing zone of the base plate and/or the sensorassembly part based on the secondary leakage parameter data, thesecondary sensing zone arranged in a secondary angle space from thecenter point of the first adhesive layer. The processor 101 isconfigured to in accordance with a detection of presence of fluid in theprimary sensing zone, transmit a primary leakage monitor signalcomprising monitor data indicative of presence of fluid in the primarysensing zone via the second interface; and in accordance with adetection of presence of fluid in the secondary sensing zone, transmit asecondary leakage monitor signal comprising monitor data indicative ofpresence of fluid in the secondary sensing zone via the secondinterface.

For monitor device 6, the ostomy data obtained from base plate and/orthe sensor assembly part may comprise tertiary leakage ostomy data froma tertiary electrode set of the base plate and/or the sensor assemblypart, wherein the processor 101 is optionally configured to: obtaintertiary leakage parameter data based on the primary leakage ostomydata; detect presence of fluid on the proximal side of the firstadhesive layer in a tertiary sensing zone of the base plate and/or thesensor assembly part based on the tertiary leakage parameter data, thetertiary sensing zone arranged in a tertiary angle space from the centerpoint of the first adhesive layer; and in accordance with a detection ofpresence of fluid in the tertiary sensing zone, transmit a tertiaryleakage monitor signal comprising monitor data indicative of presence offluid in the tertiary sensing zone via the second interface.

In monitor device 6, to detect presence of fluid on the proximal side ofthe first adhesive layer in a primary sensing zone is based on a primaryleakage criteria set based on the primary leakage parameter data,wherein fluid is present in the primary sensing zone if the primaryleakage criteria set is satisfied, and wherein the primary leakagecriteria set is based on a primary leakage threshold value stored in thememory. Further, to detect presence of fluid on the proximal side of thefirst adhesive layer in a secondary sensing zone is based on a secondaryleakage criteria set based on the secondary leakage parameter data,wherein fluid is present in the secondary sensing zone if the secondaryleakage criteria set is satisfied, and wherein the secondary leakagecriteria set is based on a secondary leakage threshold value stored inthe memory. Optionally and if a tertiary sensing zone is implemented, todetect presence of fluid on the proximal side of the first adhesivelayer in a tertiary sensing zone is based on a tertiary leakage criteriaset based on the tertiary leakage parameter data, wherein fluid ispresent in the tertiary sensing zone if the tertiary leakage criteriaset is satisfied, and wherein the tertiary leakage criteria set is basedon a tertiary leakage threshold value stored in the memory.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200with a stomal opening 18A. During use, a proximal surface of the firstadhesive layer 200 adheres to the user's skin in the peristomal areaand/or to additional seals, such as sealing paste, sealing tape and/orsealing ring. The base plate 4 optionally comprises a second adhesivelayer 202, also denoted rim adhesive layer, with a stomal opening 18B.The base plate 4 comprises a plurality of electrodes arranged in anelectrode assembly 204. The electrode assembly 204 is arranged betweenthe first adhesive layer 200 and the second adhesive layer 202. Theelectrode assembly 204 comprises a support layer with stomal opening 18Cand electrodes formed on a proximal surface of the support layer. Thebase plate 4 comprises a release liner 206 that is peeled off by theuser prior to applying the base plate 4 on the skin. The base plate 4comprises a top layer 208 with a stomal opening 18D and a coupling ring209 for coupling an ostomy pouch to the base plate 4. The top layer 208is a protective layer protecting the second adhesive layer 202 fromexternal strains and stress during use.

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the proximalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer (not shown). The first intermediate element 213covers the terminal elements forming terminals 212 of the base plate 4when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

As previously described, some parts of the illustrated base plate 4, maybe provided as a separate assembly to be applied to an existing baseplate, e.g. comprising one or more of the components as described, suchas to provide a base plate like the base plate 4 as described. Forexample, a sensor assembly part 700 may be provided, e.g. comprising theelectrode assembly 204, the first connector 211, the first intermediateelement 213, the first adhesive layer 200 and the release liner 206.Additionally, the sensor assembly part 700 may also comprise the secondadhesive layer 202 and/or the top layer 208. It may be envisioned thatthe user may provide a hole in layers of the base plate whereto thesensor assembly part 700 is to be applied, to allow for the firstconnector 211 of the sensor assembly part 700 to protrude through layersof the base plate whereto the sensor assembly part 700 is applied.Alternatively, the sensor assembly part 700 may be applied to the baseplate such that the first connector 211 is positioned outside theperiphery of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate and/or a sensor assembly part. The electrodeassembly 204 has a distal side 204A and a proximal side 204B. Theelectrode assembly 204 comprises a support layer 214 with proximalsurface 214B and electrodes 216 arranged on the proximal side of thesupport layer 214 and including a ground electrode, a first electrode, asecond electrode, a third electrode, a fourth electrode, and a fifthelectrode, wherein each electrode has a respective connection part 217for connecting the electrodes 216 to respective terminal elements of themonitor interface. The electrodes 216 are positioned and/or formed on aproximal side 214B of the support layer 214. Further, electrode assembly204 comprises a masking element 218 with proximal surface 218B andconfigured to insulate electrode parts of electrodes 216 from the firstadhesive layer of the base plate and/or the sensor assembly part. Themasking element 218 covers or overlap with parts of the electrodes 216when seen in the axial direction.

FIG. 5 is a proximal view of proximal surfaces of base plate parts ofthe base plate and/or the sensor assembly part without the firstadhesive layer and the release liner. The base plate 4 and/or the sensorassembly part 700 comprises a first intermediate element 213 on theproximal side of the electrode assembly, i.e. between the electrodeassembly 204 and the first adhesive layer (not shown). The firstintermediate element 213 covers the terminal elements of the base plate4 when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plateand/or the sensor assembly part.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrode assembly204, such as the electrode configuration 220 of the electrode assembly204 comprises a ground electrode 222, a first electrode 224, a secondelectrode 226, a third electrode 228, a fourth electrode 230, and afifth electrode 232. The ground electrode 222 comprises a groundconnection part 222A and the first electrode 224 comprises a firstconnection part 224A. The second electrode 226 comprises a secondconnection part 226A and the third electrode 228 comprises a thirdconnection part 228A. The fourth electrode 230 comprises a fourthconnection part 230A and the fifth electrode 232 comprise a fifthconnection part 232A.

The fourth electrode (second leakage electrode) 230 comprises fourthsensing parts 230B. The fifth electrode (third leakage electrode) 232comprises fifth sensing parts 232B. The ground electrode 222 comprises afirst electrode part 234 for forming a ground or reference for the firstelectrode 224. The ground electrode 222 comprises a second electrodepart 236 for forming a ground or reference for the second electrode 226.The ground electrode 222 comprises a third electrode part 238 forforming a ground or reference for the third electrode 228. The maskingelement 218 is arranged proximal to the electrodes 222, 224, 226, 228covering and insulating parts of the electrodes from the first adhesiveand forming respective conductor parts of the electrodes 222, 224, 226,228. The parts of the electrodes 222, 224, 226, 228 not covered by themasking element 219 contacts the first adhesive layer and form sensingparts 224B, 226B, 228B of electrodes 224, 226, 228, respectively.Further, the electrode parts 234, 236, 238 form sensing parts of theground electrode 222.

The first sensing part 224B extends circularly at least 330 degreesaround the stomal opening at a first radial distance R1 from the centerpoint 19, see also FIG. 11. The first radial distance R1 is 14 mm. Thefirst electrode part 234 is arranged on the inside of the first sensingpart (i.e. closer to the center point) and extends circularly at least330 degrees around the stomal opening at a first ground distance RG1from the first sensing part (radially from the center point). The firstground distance RG1 is about 1 mm.

The second sensing part 226B extends circularly at least 330 degreesaround the stomal opening at a second radial distance R2 from the centerpoint 19, see also FIG. 11. The second radial distance R2 is 18 mm. Thesecond electrode part 236 is arranged on the inside of the secondsensing part 226B (i.e. closer to the center point) and extendscircularly at least 330 degrees around the stomal opening at a secondground distance RG2 from the second sensing part 226B (radially from thecenter point). The second ground distance RG2 is about 1 mm.

The third sensing part 228B extends circularly at least 330 degreesaround the stomal opening at a third radial distance R3 from the centerpoint 19, see also FIG. 11. The third radial distance R3 is about 26 mm.The third electrode part 238 is arranged on the inside of the thirdsensing part 228B (i.e. closer to the center point) and extendscircularly at least 330 degrees around the stomal opening at a thirdground distance RG3 from the third sensing part 228B (radially from thecenter point). The third ground distance RG3 is about 1 mm.

The ground electrode 222 comprises a fourth electrode part 240 forforming a ground or reference for the fourth electrode 230 and the fifthelectrode 232. The fourth electrode part 240 of the ground electrodeforms the first leakage electrode. The fourth electrode part 240 of theground electrode 222 extends at least 300 degrees around the stomalopening and comprises ground sensing parts 222B. The fourth sensingparts 230B, fifth sensing parts 232B, and ground sensing parts of thefourth electrode part 240 are circularly distributed around the centerpoint 19 at a leakage radius from the center point. The fourth sensingparts 230B, fifth sensing parts 232B, and ground sensing parts of thefourth electrode part may have a radial extension larger than 1.0 mm,such as in the range from 1.5 mm to 3.0 mm, e.g. about 2.0 mm. Thefourth sensing parts 230B, fifth sensing parts 232B, and ground sensingparts of the fourth electrode part 240 may have a circumferentialextension (perpendicular to the radial extension) larger than 1.0 mm,such as in the range from 2.5 mm to 5.0 mm, e.g. about 3.5 mm. In one ormore exemplary base plates, the electrodes 224, 226, 228 and electrodeparts 234, 236, 238 may be omitted from the electrodeconfiguration/electrode assembly.

FIG. 7 is a distal view of an exemplary masking element. The maskingelement 218 optionally has a plurality of terminal openings includingsix terminal openings. The plurality of terminal openings comprises aground terminal opening 242, a first terminal opening 244, a secondterminal opening 246, a third terminal opening 248, a fourth terminalopening 250, and a fifth terminal opening 252. The terminal openings242, 244, 246, 248, 250, 252 of the masking element 218 are configuredto overlap and/or be aligned with respective connection parts 222A,224A, 226A, 228A, 230A, 232A of the electrodes of the electrodeassembly.

The masking element 218 has a plurality of sensor point openings. Thesensor point openings comprise primary sensor point openings shownwithin dotted line 254, each primary sensor point opening configured tooverlap a part of the ground electrode (first leakage electrode) 222and/or a part of the fourth electrode (second leakage electrode) 230.The primary sensor point openings 254 comprise, in the illustratedexemplary masking element, five primary sensor point openings 254A eachconfigured to overlap a respective sensing part of the ground electrode(first leakage electrode) 222. The primary sensor point openings 254comprise, in the illustrated exemplary masking element, four primarysensor point openings 254B each configured to overlap a respectivesensing part of the fourth electrode (second leakage electrode) 230. Thesensor point openings comprise secondary sensor point openings shownwithin dotted line 256, each second sensor point opening configured tooverlap a part of the fourth electrode (second leakage electrode) 230and/or a part of the fifth electrode (third leakage electrode) 232. Thesecondary sensor point openings 256 comprise, in the illustratedexemplary masking element, five secondary sensor point openings 256Aeach configured to overlap a respective sensing part of the fifthelectrode (third leakage electrode) 232. The secondary sensor pointopenings 256 comprise, in the illustrated exemplary masking element,four secondary sensor point openings 256B each configured to overlap arespective sensing part of the fourth electrode (second leakageelectrode) 230. The sensor point openings comprise tertiary sensor pointopenings shown within dotted line 258, each tertiary sensor openingconfigured to overlap a part of the fifth electrode (third leakageelectrode) 232 and/or a part of the ground electrode (first leakageelectrode) 222. The tertiary sensor point openings 258 comprise, in theillustrated exemplary masking element, five tertiary sensor pointopenings 258A each configured to overlap a respective sensing part ofthe fifth electrode (third leakage electrode) 232. The tertiary sensorpoint openings 258 comprise, in the illustrated exemplary maskingelement, four tertiary sensor point openings 258B each configured tooverlap a respective sensing part of the ground electrode (first leakageelectrode) 222. The sensor point openings 254A, 254B, 256A, 256B, 258A,258B, are circularly arranged at a leakage radius of about 30 mm fromthe center point 19.

FIG. 8 is a distal view of an exemplary first adhesive layer. The firstadhesive layer 200 has a plurality of sensor point openings. The sensorpoint openings of the first adhesive layer comprise primary sensor pointopenings shown within dotted line 260, each primary sensor point openingconfigured to overlap a part of the ground electrode 222 and/or a partof the fourth electrode 230 of the electrode assembly. The primarysensor point openings comprise, in the illustrated exemplary firstadhesive layer, five primary sensor point openings 260A each configuredto overlap a respective sensing part of the ground electrode 222. Theprimary sensor point openings comprise, in the illustrated exemplaryfirst adhesive layer, four primary sensor point openings 260B eachconfigured to overlap a respective sensing part of the fourth electrode230. The sensor point openings of the first adhesive layer comprisesecondary sensor point openings shown within dotted line 262, eachsecond sensor point opening configured to overlap a part of the fourthelectrode 230 and/or a part of the fifth electrode 232 of the electrodeassembly. The secondary sensor point openings comprise, in theillustrated exemplary first adhesive layer, five secondary sensor pointopenings 262A each configured to overlap a respective sensing part ofthe fifth electrode 232. The secondary sensor point openings comprise,in the illustrated exemplary first adhesive layer, four secondary sensorpoint openings 262B each configured to overlap a respective sensing partof the fourth electrode 230. The sensor point openings of the firstadhesive layer comprise tertiary sensor point openings shown withindotted line 264, each tertiary sensor opening configured to overlap apart of the fifth electrode 232 and/or a part of the ground electrode222 of the electrode assembly. The tertiary sensor point openingscomprise, in the illustrated exemplary first adhesive layer, fivetertiary sensor point openings 264A each configured to overlap arespective sensing part of the fifth electrode 232. The tertiary sensorpoint openings comprise, in the illustrated exemplary first adhesivelayer, four tertiary sensor point openings 264B each configured tooverlap a respective sensing part of the ground electrode 222.

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8. Thesensor point openings 260A, 260B, 262A, 262B, 264A, 264B, are circularlyarranged at a leakage radius of about 30 mm from the center point.

FIG. 10 is a more detailed distal view of a part of the base plate 4and/or the sensor assembly part 700. The base plate 4 and/or the sensorassembly part 700 comprises a monitor interface. The monitor interfacecomprises the first connector 211. The first connector 211 comprisescoupling part 210 configured to releasably couple the monitor device tothe base plate and/or the sensor assembly part and thus forming areleasable coupling. The first connector 211 of the monitor interfacecomprises a plurality of terminals formed by respective terminalelements for forming respective electrical connections with respectiveterminals of the monitor device.

The plurality of terminals of the first connector 211 of the monitorinterface comprises a ground terminal element 282 forming a groundterminal 282A, a first terminal element 284 forming a first terminal284, a second terminal element 286 forming a second terminal 286A, andoptionally a third terminal element 288 forming a third terminal 288A.The monitor interface optionally comprises a fourth terminal element 290forming a fourth terminal 290A and/or a fifth terminal element 292forming a fifth terminal 292A. The terminal elements 282, 284, 286, 288,290, 292 contact respective connection parts 222A, 224A, 226A, 228A,230a, 232A of electrodes 222, 224, 226, 228, 230, 232.

The position of the first connector on the base plate and/or the sensorassembly part, the number of terminals and the position of the terminalsin the coupling part may be adapted to the electrode configuration usedin the electrode assembly of the base plate and/or the sensor assemblypart. For example, a first connector for a base plate and/or a sensorassembly part with the electrode configuration 220A shown in FIG. 11comprises four terminals respectively connected to connection parts222A, 224A, 226A, 228A of the electrodes, and a first connector for abase plate and/or a sensor assembly part with the electrodeconfiguration 220B shown in FIG. 12 comprises three terminalsrespectively connected to connection parts 222A, 224A, 226A of theelectrodes.

FIG. 11 is a distal view of the exemplary electrode configuration 220 ofFIG. 6 for a base plate and/or a sensor assembly part. The electrodeconfiguration 220 comprises a first leakage electrode 222, secondleakage electrode 230, and third leakage electrode 232. The leakageelectrodes 222, 230, 232 are configured to detect presence of fluid onthe proximal side of the first adhesive layer in three angular sensingzones, primary sensing zone 400, secondary sensing zone 402, andtertiary sensing zone 404. The primary sensing zone 400 is arranged in aprimary angle space between a first direction 406 and a second direction408 from the center point 19, wherein the primary angle space spans aprimary angle V1 of 120°. The secondary sensing zone 402 is arranged ina secondary angle space between the second direction 408 and a thirddirection 410 from the center point 19, wherein the secondary anglespace spans a secondary angle V2 of 120°. The tertiary sensing zone 404is arranged in a tertiary angle space between the third direction 410and the first direction 406 from the center point 19, wherein thetertiary angle space spans a tertiary angle V3 of 120°.

The first leakage electrode 222 comprises five primary sensing parts222D arranged in the primary sensing zone 400, and four tertiary sensingparts 222E arranged in the tertiary sensing zone 404. Each primarysensing part 222D is aligned with a respective primary sensor pointopening 254A of the masking element 218 (see FIG. 7). Further, eachprimary sensing part 222D is aligned with a respective primary sensorpoint opening 260A of the first adhesive layer 200 (see FIG. 8). Eachtertiary sensing part 222E of the first leakage electrode 222 is alignedwith a respective tertiary sensor point opening 258B of the maskingelement 218 (see FIG. 7). Further, each tertiary first sensing part 222Eis aligned with a respective tertiary sensor point opening 264B of thefirst adhesive layer 200 (see FIG. 8).

The second leakage electrode 230 comprises four primary sensing parts230D arranged in the primary sensing zone 400, and four secondarysensing parts 230E arranged in the secondary sensing zone 402. Eachprimary sensing part 230D is aligned with a respective primary sensorpoint opening 254B of the masking element 218 (see FIG. 7). Further,each primary sensing part 230D is aligned with a respective primarysensor point opening 260B of the first adhesive layer 200 (see FIG. 8).Each secondary sensing part 230E is aligned with a respective secondarysensor point opening 256B of the masking element 218 (see FIG. 7).Further, each secondary sensing part 230E is aligned with a respectivesecondary sensor point opening 262B of the first adhesive layer 200 (seeFIG. 8).

The third leakage electrode 232 comprises five secondary sensing parts232D arranged in the secondary sensing zone 402, and five tertiarysensing parts 232E arranged in the tertiary sensing zone 404. Eachsecondary sensing part 232D is aligned with a respective secondarysensor point opening 256A of the masking element 218 (see FIG. 7).Further, each secondary sensing part 232D is aligned with a respectivesecondary sensor point opening 262A of the first adhesive layer 200 (seeFIG. 8). Each tertiary sensing part 232E is aligned with a respectivetertiary sensor point opening 258A of the masking element 218 (see FIG.7). Further, each tertiary sensing part 232E is aligned with arespective tertiary sensor point opening 264A of the first adhesivelayer 200 (see FIG. 8). The sensing parts 222D, 222E, 230D, 230E, 232D,232E are circularly arranged at a leakage radius RL of about 30 mm fromthe center point.

FIG. 12 is a distal view of an exemplary electrode configuration 220Afor a base plate and/or a sensor assembly part. The electrodeconfiguration 220 comprises a first leakage electrode 222, secondleakage electrode 230, and third leakage electrode 232. The leakageelectrodes 222, 230, 232 are configured to detect presence of fluid onthe proximal side of the first adhesive layer in two angular sensingzones, primary sensing zone 400 and secondary sensing zone 402. Theprimary sensing zone 400 is arranged in a primary angle space between afirst direction 406 and a second direction 408 from the center point 19,wherein the primary angle space spans a primary angle V1 of about 185°.The secondary sensing zone 402 is arranged in a secondary angle spacebetween the second direction 408 and the first direction 406 from thecenter point 19, wherein the secondary angle space spans a secondaryangle V2 of about 175°.

The first leakage electrode 222 comprises primary sensing parts 222Darranged in the primary sensing zone 400, and secondary sensing parts222F arranged in the secondary sensing zone 402. The second leakageelectrode 230 comprises primary sensing parts 230D arranged in theprimary sensing zone 400. The third leakage electrode 232 comprisessecondary sensing parts 232D arranged in the secondary sensing zone 402.Each primary sensing part 222D, 230D is aligned with a respectiveprimary sensor point opening of the masking element 219 (see FIG. 13)and with a respective primary sensor point opening of the first adhesivelayer 201 (see FIG. 14). The sensing parts 222D, 222F, 230D, and 232Dare circularly arranged at a leakage radius RL of about 30 mm from thecenter point.

FIG. 13 is a distal view of masking layer 219 for electrodeconfiguration 220A in FIG. 12. The masking layer 219 comprises primarysensor point openings 254 in the primary angle space and secondarysensor point openings 256 in the secondary angle space. FIG. 14 is adistal view of first adhesive layer 201 for electrode configuration 220Ain FIG. 12 implementing a base plate and/or a sensor assembly part withtwo sensing zones arranged in separate angle spaces. The first adhesivelayer 201 comprises primary sensor point openings 260 in the primaryangle space and secondary sensor point openings 262 arranged in thesecondary angle space.

FIG. 15 is a distal view of an exemplary electrode configuration 220Bfor a base plate and/or a sensor assembly part. The electrodeconfiguration 220B comprises first leakage electrode 222, second leakageelectrode 230, third leakage electrode 232, fourth leakage electrode412, and fifth leakage electrode 414. The leakage electrodes 222, 230,232, 412, 414 are configured to detect presence of fluid on the proximalside of the first adhesive layer in four angular sensing zones 400, 402,404, 416. The primary sensing zone 400 is arranged in a primary anglespace spanning a primary angle V1 of about 85°. The secondary sensingzone 402 is arranged in a secondary angle space spanning a secondaryangle V2 of about 95°. The tertiary sensing zone 404 is arranged in atertiary angle space spanning a tertiary angle V3 of about 95°. Thequaternary sensing zone 416 is arranged in a quaternary angle spacespanning a quaternary angle V4 of about 85°.

While exemplary base plates and/or sensor assembly parts with two, threeand four sensing zones have been described in more detail, the baseplate and/or the sensor assembly part may comprise one or a largernumber of sensing zones, such as five, six, seven, eight or more sensingzones.

FIG. 16 is a flow diagram of an exemplary method of monitoring a baseplate and/or a sensor assembly part of an ostomy appliance, the baseplate and/or the sensor assembly part comprising a first adhesive layerand a plurality of electrodes, the first adhesive layer having aproximal side configured for attachment of the base plate and/or thesensor assembly part to the skin surface of a user and a stomal openingwith a center point, the plurality of electrodes including a firstleakage electrode, a second leakage electrode, and a third leakageelectrode. The method 1000 comprises obtaining 1002 a primary sensorsignal (primary leakage ostomy data) from the first leakage electrodeand the second leakage electrode; detecting 1004 presence of fluid onthe proximal side in a primary sensing zone based on the primary sensorsignal (primary leakage ostomy data); obtaining 1006 a secondary sensorsignal (secondary leakage ostomy data) from the second leakage electrodeand the third leakage electrode; detecting 1008 presence of fluid on theproximal side in a secondary sensing zone based on the secondary sensorsignal (secondary leakage ostomy data); and in accordance 1010 withdetection of presence of fluid in the primary sensing zone and/or thesecondary sensing zone, providing 1012 a leakage indicator, e.g. awireless monitor signal to an accessory device from a monitor device,indicative of the sensing zone in which presence of liquid has beendetected. If no fluid is detected, the method returns to obtaining 1002a primary sensor signal (primary leakage ostomy data) from the firstleakage electrode and the second leakage electrode.

The method 1000 comprises obtaining 1002 a primary sensor signal(primary leakage ostomy data) from the first leakage electrode and thesecond leakage electrode; detecting 1004 presence of fluid on theproximal side in a primary sensing zone based on the primary sensorsignal (primary leakage ostomy data); obtaining 1006 a secondary sensorsignal (secondary leakage ostomy data) from the second leakage electrodeand the third leakage electrode; detecting 1008 presence of fluid on theproximal side in a secondary sensing zone based on the secondary sensorsignal (secondary leakage ostomy data); and in accordance 1010 withdetection of presence of fluid in the primary sensing zone and/or thesecondary sensing zone, providing 1012 a leakage indicator, e.g. awireless monitor signal to an accessory device from a monitor device,indicative of the sensing zone in which presence of liquid has beendetected. If no fluid is detected, the method returns to obtaining 1002a primary sensor signal (primary leakage ostomy data) from the firstleakage electrode and the second leakage electrode.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. does not imply any particular order, butare included to identify individual elements. Moreover, the use of theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not denote any order or importance, but rather theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used to distinguish one element from another. Notethat the words “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. are used here and elsewhere for labellingpurposes only and are not intended to denote any specific spatial ortemporal ordering. Furthermore, the labelling of a first element doesnot imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications, and equivalents.

Embodiments of the present disclosure are set out in the followingitems:

1. A monitor device for an ostomy system comprising an ostomy appliancewith a sensor assembly part having a first adhesive layer with aproximal side configured for attachment of the sensor assembly part tothe skin surface of a user, the first adhesive layer having a stomalopening with a center point, the monitor device comprising:

-   -   a processor;    -   memory;    -   a first interface connected to the processor and the memory, the        first interface configured for obtaining ostomy data from the        sensor assembly part coupled to the first interface, the ostomy        data comprising primary leakage ostomy data from a primary        electrode set of the sensor assembly part and secondary leakage        ostomy data from a secondary electrode set of the sensor        assembly part; and    -   a second interface connected to the processor, wherein the        processor is configured to:    -   obtain primary leakage parameter data based on the primary        leakage ostomy data;    -   obtain secondary leakage parameter data based on the secondary        leakage ostomy data;    -   detect presence of fluid on the proximal side of the first        adhesive layer in a primary sensing zone based on the primary        leakage parameter data, the primary sensing zone arranged in a        primary angle space from the center point of the first adhesive        layer;    -   detect presence of fluid on the proximal side of the first        adhesive layer in a secondary sensing zone based on the        secondary leakage parameter data, the secondary sensing zone        arranged in a secondary angle space from the center point of the        first adhesive layer;    -   in accordance with a detection of presence of fluid in the        primary sensing zone, transmit a primary leakage monitor signal        comprising monitor data indicative of presence of fluid in the        primary sensing zone via the second interface; and    -   in accordance with a detection of presence of fluid in the        secondary sensing zone, transmit a secondary leakage monitor        signal comprising monitor data indicative of presence of fluid        in the secondary sensing zone via the second interface.

2. Monitor device according to item 1, wherein the ostomy data comprisestertiary leakage ostomy data from a tertiary electrode set of the sensorassembly part, wherein the processor is configured to:

-   -   obtain tertiary leakage parameter data based on the primary        leakage ostomy data;    -   detect presence of fluid on the proximal side of the first        adhesive layer in a tertiary sensing zone based on the tertiary        leakage parameter data, the tertiary sensing zone arranged in a        tertiary angle space from the center point of the first adhesive        layer; and    -   in accordance with a detection of presence of fluid in the        tertiary sensing zone, transmit a tertiary leakage monitor        signal comprising monitor data indicative of presence of fluid        in the tertiary sensing zone via the second interface.

3. Monitor device according to any of items 1-2, wherein to detectpresence of fluid on the proximal side of the first adhesive layer in aprimary sensing zone is based on a primary leakage criteria set based onthe primary leakage parameter data, wherein fluid is present in theprimary sensing zone if the primary leakage criteria set is satisfied.

4. Monitor device according to item 3, wherein the primary leakagecriteria set is based on a primary leakage threshold value stored in thememory.

5. Monitor device according to any of items 1-4, wherein to detectpresence of fluid on the proximal side of the first adhesive layer in asecondary sensing zone is based on a secondary leakage criteria setbased on the secondary leakage parameter data, wherein fluid is presentin the secondary sensing zone if the secondary leakage criteria set issatisfied.

6. Monitor device according to item 5, wherein the secondary leakagecriteria set is based on a secondary leakage threshold value stored inthe memory.

7. Monitor device according to any of items 1-6 as dependent on item 2,wherein to detect presence of fluid on the proximal side of the firstadhesive layer in a tertiary sensing zone is based on a tertiary leakagecriteria set based on the tertiary leakage parameter data, wherein fluidis present in the tertiary sensing zone if the tertiary leakage criteriaset is satisfied.

8. Monitor device according to item 7, wherein the tertiary leakagecriteria set is based on a tertiary leakage threshold value stored inthe memory.

9. Monitor device according to any of items 1-8, wherein the secondinterface comprises a loudspeaker connected to the processor, andwherein the processor is configured to transmit a monitor signal via theloudspeaker.

10. Monitor device according to any of items 1-9, wherein the secondinterface comprises an antenna and a wireless transceiver, and whereinthe processor is configured to transmit a monitor signal as a wirelessmonitor signal via the antenna and the wireless transceiver.

11. An ostomy system comprising an ostomy appliance and a monitordevice, the ostomy appliance comprising a sensor assembly part, whereinthe monitor device is a monitor device according to any of items 1-10.

12. Ostomy system according to item 11 comprising a base plate, andwherein the sensor assembly part is configured to be attached to aproximal side of the base plate.

LIST OF REFERENCES

1 ostomy system

2 ostomy appliance

4 base plate

6 monitor device

8 accessory device

10 server device

12 network

14 coupling member

16 coupling ring

18, 18A, 18B, 18C, 18D stomal opening

20 docking station

22 first connector

24 user interface

100 monitor device housing

101 processor

102 first interface

104 second interface

106 memory

108 ground terminal of monitor device

110 first terminal of monitor device

112 second terminal of monitor device

114 third terminal of monitor device

116 fourth terminal of monitor device

118 fifth terminal of monitor device

120 coupling part

121 power unit

122 antenna

124 wireless transceiver

126 loudspeaker

128 haptic feedback element

140 sensor unit

200, 201 first adhesive layer

200A distal surface of first adhesive layer

200B proximal surface of first adhesive layer

202 second adhesive layer

202A distal surface of second adhesive layer

202B proximal surface of second adhesive layer

204 electrode assembly

204A distal surface of electrode assembly

204B proximal surface of electrode assembly

206 release liner

206A distal surface of the release liner

206B proximal surface of the release liner

208 top layer

208A distal surface of the top layer

208B proximal surface of the top layer

209 coupling ring

210 coupling part of first connector

211 first connector

212 terminals of first connector

213 first intermediate element

213A distal surface of first intermediate element

213B proximal surface of first intermediate element

214 support layer of electrode assembly

214A distal surface of support layer

214B proximal surface of support layer

216 electrodes of electrode assembly

217 connection parts of electrodes

218, 219 masking element

218A distal surface of masking element

218B proximal surface of masking element

220, 220A, 220B electrode configuration

222 ground electrode, first leakage electrode

222A ground connection part

222B ground sensing part, sensing part of first leakage electrode

222C ground connector part

222D primary sensing part

222E tertiary sensing part

222F secondary sensing part

224 first electrode

224A first connection part

224B first sensing part

224C first conductor part

226 second electrode

226A second connection part

226B second sensing part

226C second conductor part

228 third electrode

228A third connection part

228B third sensing part

228C third conductor part

230 fourth electrode, second leakage electrode

230A fourth connection part

230B fourth sensing part, sensing part of second leakage electrode

230D primary sensing part

230E secondary sensing part

232 fifth electrode, third leakage electrode

232A fifth connection part

232B fifth sensing part, sensing part of third leakage electrode

232D secondary sensing part

232E tertiary sensing part

234 first electrode part of the ground electrode

236 second electrode part of the ground electrode

238 third electrode part of the ground electrode

240 fourth electrode part of the ground electrode

242 ground terminal opening

244 first terminal opening

246 second terminal opening

248 third terminal opening

250 fourth terminal opening

252 fifth terminal opening

254 primary sensor point openings of masking element

254A primary sensor point opening for the ground electrode (firstleakage electrode)

254B primary sensor point opening for the fourth electrode (secondleakage electrode)

256 secondary sensor point openings of masking element

256A secondary sensor point opening for the fifth electrode (thirdleakage electrode)

256B secondary sensor point opening for the fourth electrode (secondleakage electrode)

258 tertiary sensor point openings of masking element

258B tertiary sensor point opening for the fifth electrode (thirdleakage electrode)

258A tertiary sensor point opening for the ground electrode (firstleakage electrode)

260 primary sensor point openings of first adhesive layer

260A primary sensor point opening for the ground electrode (firstleakage electrode)

260B primary sensor point opening for the fourth electrode (secondleakage electrode)

262 secondary sensor point openings of first adhesive layer

262A secondary sensor point opening for the fifth electrode (thirdleakage electrode)

262B secondary sensor point opening for the fourth electrode (secondleakage electrode)

264 tertiary sensor point openings of first adhesive layer

264A tertiary sensor point opening for the fifth electrode (thirdleakage electrode)

264B tertiary sensor point opening for the ground electrode (firstleakage electrode)

282 ground terminal element

282A ground terminal

284 first terminal element

284A first terminal

286 second terminal element

286A second terminal

288 third terminal element

288A third terminal

290 fourth terminal element

290A fourth terminal

292 fifth terminal element

292A fifth terminal

400 primary sensing zone

402 secondary sensing zone

404 tertiary sensing zone

406 first direction/zero direction

408 second direction

410 third direction

412 fourth leakage electrode

414 fifth leakage electrode

416 quaternary sensing zone

418 fourth direction

700 sensor assembly part

1000 method of monitoring a base plate of an ostomy appliance

1002 obtaining a primary sensor signal

1004 detecting presence of fluid in a primary sensing zone

1006 obtaining a secondary sensor signal

1008 detecting presence of fluid in a secondary sensing zone

1010 presence of fluid detected

1012 providing a leakage indicator

R1 first radial distance

RG1 first ground distance

R2 second radial distance

RG2 second ground distance

R3 third radial distance

RG3 third ground distance

RL leakage radius

V1 primary angle

V2 secondary angle

V3 tertiary angle

V4 tertiary angle

1. A monitor device for a medical system comprising a medical appliancewith a base plate having a first adhesive layer with a proximal sideconfigured for attachment of the base plate to the skin surface of auser, the first adhesive layer having a stomal opening with a centerpoint, the monitor device comprising: a processor; memory; a firstinterface connected to the processor and the memory, the first interfaceconfigured for obtaining data from the base plate coupled to the firstinterface, the data comprising primary leakage data from a primaryelectrode set of the base plate and secondary leakage data from asecondary electrode set of the base plate; and a second interfaceconnected to the processor, wherein the processor is configured to:obtain primary leakage parameter data based on the primary leakage data;obtain secondary leakage parameter data based on the secondary leakagedata; detect presence of fluid on the proximal side of the firstadhesive layer in a primary sensing zone based on the primary leakageparameter data, the primary sensing zone arranged in a primary anglespace from the center point of the first adhesive layer; detect presenceof fluid on the proximal side of the first adhesive layer in a secondarysensing zone based on the secondary leakage parameter data, thesecondary sensing zone being separate from the primary sensing zone andarranged in a secondary angle space from the center point of the firstadhesive layer; in accordance with a detection of presence of fluid inthe primary sensing zone, transmit a primary leakage monitor signalcomprising monitor data indicative of presence of fluid in the primarysensing zone via the second interface; and in accordance with adetection of presence of fluid in the secondary sensing zone, transmit asecondary leakage monitor signal comprising monitor data indicative ofpresence of fluid in the secondary sensing zone via the secondinterface.
 2. The monitor device according to claim 1, wherein the datacomprises tertiary leakage data from a tertiary electrode set of thebase plate, wherein the processor is configured to: obtain tertiaryleakage parameter data based on the primary leakage data; detectpresence of fluid on the proximal side of the first adhesive layer in atertiary sensing zone based on the tertiary leakage parameter data, thetertiary sensing zone arranged in a tertiary angle space from the centerpoint of the first adhesive layer; and in accordance with a detection ofpresence of fluid in the tertiary sensing zone, transmit a tertiaryleakage monitor signal comprising monitor data indicative of presence offluid in the tertiary sensing zone via the second interface.
 3. Themonitor device according to claim 1, wherein to detect presence of fluidon the proximal side of the first adhesive layer in a primary sensingzone is based on a primary leakage criteria set based on the primaryleakage parameter data, wherein fluid is present in the primary sensingzone if the primary leakage criteria set is satisfied.
 4. the monitordevice according to claim 3, wherein the primary leakage criteria set isbased on a primary leakage threshold value stored in the memory.
 5. Themonitor device according to claim 1, wherein to detect presence of fluidon the proximal side of the first adhesive layer in a secondary sensingzone is based on a secondary leakage criteria set based on the secondaryleakage parameter data, wherein fluid is present in the secondarysensing zone if the secondary leakage criteria set is satisfied.
 6. Themonitor device according to claim 5, wherein the secondary leakagecriteria set is based on a secondary leakage threshold value stored inthe memory.
 7. The monitor device according to claim 2, wherein todetect presence of fluid on the proximal side of the first adhesivelayer in a tertiary sensing zone is based on a tertiary leakage criteriaset based on the tertiary leakage parameter data, wherein fluid ispresent in the tertiary sensing zone if the tertiary leakage criteriaset is satisfied.
 8. The monitor device according to claim 7, whereinthe tertiary leakage criteria set is based on a tertiary leakagethreshold value stored in the memory.
 9. The monitor device according toclaim 1, wherein the second interface comprises a loudspeaker connectedto the processor, and wherein the processor is configured to transmit amonitor signal via the loudspeaker.
 10. The monitor device according toclaim 1, wherein the second interface comprises an antenna and awireless transceiver, and wherein the processor is configured totransmit a monitor signal as a wireless monitor signal via the antennaand the wireless transceiver.
 11. A medical system comprising an ostomyappliance and a monitor device, the ostomy appliance comprising a baseplate, wherein the monitor device is a monitor device according to claim1.